CARDIOCAP(TM) CT-104 MONITOR— 510(k) K897080

Substantially Equivalent

Datex Division Instrumentarium Corp.

FDA 510(k) clearance K897080 for CARDIOCAP(TM) CT-104 MONITOR, Substantially Equivalent on 1990-03-06. Applicant: Datex Division Instrumentarium Corp..

Clearance details

Applicant: Datex Division Instrumentarium Corp.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1989-12-21
Decision date: 1990-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, Finland, FI

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Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.